Shots:

• The approval is based on four P-III trials: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults and Studies 1844 and 1878 in virologically suppressed adults assessing Biktarvy or an active comparator regimen in 2-414 patients
• The study met its 1EP of non-inferiority at 48 weeks across all four studies with none of the patients developed treatment-emergent virologic resistance and no discontinuation due to renal- bone or hepatic adverse events
•  Biktarvy (qd) is an INSTI-based triple-therapy STR combining bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg (BIC/FTC/TAF) approved for HIV-1 Infection in Japan. Additionally- the product has a box warning regarding the risk of post-treatment acute exacerbation of hepatitis B

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